The various embodiments relate generally to surgical devices for forming an anastomosis between organs, and more particularly, to devices that can be inserted through a natural orifice in the body and used to form an anastomosis between various gastrointestinal organs.
Access to the abdominal cavity may be required, from time to time, for diagnostic and therapeutic endeavors for a variety of medical and surgical procedures. Historically, abdominal access has required a formal laparotomy, e.g., abdominal surgery through a surgical incision made in the wall of the abdomen to provide adequate exposure. Such procedures, however, require incisions to be made in the abdomen and may not be particularly well-suited for patients having extensive abdominal scarring from previous procedures, persons who are morbidly obese, individuals with abdominal wall infection, and patients with diminished abdominal wall integrity, such as patients with burns and skin grafting. Other patients simply do not want to have a scar if it can be avoided.
Such conventional open surgical procedures also are employed to address various problems occurring in the gastrointestinal tract, such as the stomach, duodenum, bile duct, jejunum (a portion of the small intestine), colon, ileum, or bowels. Surgical procedures in the gastrointestinal tract are generally performed to treat obese patients, e.g., to decrease absorption of nutrients, and to treat blockages, obstructions, or strictures in the gastrointestinal tact. Blockages, obstructions, or strictures may occur in the duodenum, bile duct, jejunum, or bowels from disease processes such as malignant or benign cancers or tumors and may be treated by using stents or creating an anastomosis between organs in the gastrointestinal tract.
Conventional surgical procedures are employed to insert stents within a blocked, obstructed, or narrowed viscus to provide palliative relief. The stents are located within the viscus to restore or provide some degree of drainage of fluid through the blocked, obstructed, or narrowed viscus. A limitation of stents is the tendency of occlusion and cholangitis resulting from the development of bacterial biofilm. Plastic stents provide a relatively narrow luminal size and therefore lead to a high occlusion rate. Metal expandable stents, despite having significantly increased patency and longer life than plastic stents, also are prone to occlusion and are extremely expensive. Stents may be located within the bile duct, for example, to provide palliative relief of obstructive jaundice resulting from blockages occurring in the bile duct. Rather than stenting the obstruction, creating a permanent fistula of larger diameter than the bile duct between the bile duct and the duodenum provides greater drainage of bile. Therefore, there is a need to provide a new method and apparatus for forming a biliary duodenal anastomosis. There is also a need for a new method and apparatus for forming a biliary drainage anastomosis by forming a choledochoduodenostomy above the ampulla.
Anastomosis is the joining of luminal structures within the body by way of collateral channels when the natural channels are blocked. Common examples are colonic anastomosis in which two portions of the colon are joined together. The anastomosis may be formed between various organs in the gastrointestinal tract. A gastro-jejunostomy anastomosis may be created between the stomach and the jejunum to treat blockages in the duodenum or for malabsorption, e.g., gastric bypass surgery. An entero-enteral anastomosis may be created for jejuno-jeunal bariatric purposes, a colon to ileum anastomosis may be created for bypassing colorectal cancer, and a biliary duodenal anastomosis may be created between the bile duct and the duodenum above a malignant or benign obstruction in the bile duct. Some anastomoses are created using compression techniques. Certain procedures also may require large openings in the bowel wall. Anastomoses also may be formed using linear staplers and require two large centimeter sized holes to be formed in the patient. Thus, most gastrointestinal anastomoses are created using open surgical procedures requiring the patient to be placed under general anesthesia and large incisions in the abdominal wall. Attendant disadvantages of such open surgical procedures include the necessity for general anesthesia, increased post-operative pain, intra-abdominal adhesions, as well as in-patient hospitalization with associated inconvenience and costs.
Some anastomoses may be created by compression or sutureless techniques. A compression anastomosis is formed by necrotic ischemia caused by the occlusion of the blood supply to the tissue. Compression is applied to the tissue using one or more masses to sandwich the tissue in the target area. One compression anastomosis technique employs a compression button that erodes through the bowel wall over several days because of ischemic necrosis resulting in a leak free anastomosis. Another sutureless compression anastomosis technique employs a bio-fragmentable ring to create an anastomosis in the bowel. This technique compared favorably to sutured and stapled anastomosis. Other anastomoses may be created using flexible endoscopy techniques employing spring compression buttons. Flexible endoscopy anastomosis techniques may employ ultrasonography techniques when access is limited to a single endoscopic lumen. Magnets also have been used to form compression anastomoses when access is possible to both transgastric lumens or by passing a device through the jejunum. Magnetic compression gastroenteric anastomosis may be performed by introducing magnets perorally with endoscopic and fluoroscopic guidance and mated across the gastric and jejunal walls. Compression anastomosis may be formed between bile ducts using magnets following duct stenosis in liver transplant patients. In addition to suffering from the limitations discussed above, current open, laparoscopic, and endoscopic surgical techniques fail to provide a convenient way for inserting a distal mass into the gastrointestinal tract and are generally incapable of applying sufficient mass and force to accomplish a clinically acceptable compression anastomosis.
Therefore, there is a need for an alternative to conventional surgery that eliminates abdominal incisions and incision-related complications to diagnose and treat abdominal pathology. There is a need for a new method and apparatus for forming a compression anastomosis. Also, there is a need for a surgical method and apparatus for forming an anastomosis between luminal structures or organs using a minimally invasive surgical technique. More particularly, there is a need for a surgical apparatus for forming anastomosis between various gastrointestinal organs that can be inserted through a natural orifice in the body using a minimally invasive surgical technique. Further, there is a need for a surgical apparatus that can be introduced into the stomach through the mouth for creating clinically acceptable compression anastomosis between the stomach and the jejunum, the colon and the ileum, and/or the bile duct and the duodenum (e.g., biliary-duodenal anastomosis) using minimally invasive surgical techniques. The foregoing discussion is intended only to illustrate some of the shortcomings present in the field at the time, and should not be taken as a disavowal of claim scope.